Consequently, the effects of overdosage are likely to be short-lived provided that administration is discontinued.

Effects of overdosage are likely to be related to the pharmacological actions and include tachycardia, tremulousness and tremor, nausea and vomiting, and anginal pain. Treatment should be supportive and directed to these symptoms.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

 The primary actions of Dopacard (dopexamine hydrochloride) are the stimulation of adrenergic β2-receptors and peripheral dopamine receptors of DA1 and DA2 subtypes. In addition, Dopacard is an inhibitor of neuronal re-uptake of noradrenaline (Uptake-1). These pharmacological actions result in an increase in cardiac output mediated by afterload reduction (β2, DA1) and mild positive inotropism β2, Uptake-1 inhibition) together with an increase in blood flow to vascular beds (DA1) such as the renal and mesenteric beds and also peripherally.

Dopacard is not an α-adrenergic agonist and does not cause vasoconstriction and is not a pressor agent.

Experience in clinical trials has shown that Dopacard can increase cardiac output by over 100% within the recommended dose range and increases of the order of 50% are frequently achieved at doses of 1-2 micrograms/kg/min without a clinically significant effect on heart rate.

5.2 Pharmacokinetic properties

 Dopacard is readily eliminated from blood with a half-life of approximately 6-7 minutes in healthy volunteers and around 11 minutes in patients with cardiac failure.

Subsequent elimination of the metabolites is by urinary and biliary excretion. The response to Dopacard is rapid in onset and effects subside rapidly on discontinuation of the infusion. Increases in dose may be made at intervals of not less than 15 minutes.

5.3 Preclinical safety data

 There are no additional safety data of relevance to the prescriber which have not already been stated in the SmPC.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

 Disodium edetate

Hydrochloric acid

Water for injections

6.2 Incompatibilities

 This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Dopacard should not be added to Sodium Bicarbonate or any other strongly alkaline solution, as inactivation will occur.

Contact with metal parts, in infusion apparatus for example, should be minimised.

6.3 Shelf life

 The shelf life for unopened ampoules is three years.

Chemical and physical in-use stability of prepared intravenous solutions in 0.9% Sodium Chloride Injection or 5% Dextrose Injection has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be diluted and used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

 Store below 25°C

Keep the ampoule in the outer carton in order to protect from light and moisture.

For storage of sterile products that have been opened, diluted o